CytRx Corporation has reported results from a previously-announced double-blind, placebo-controlled clinical trial in healthy volunteers indicating that its drug candidate arimoclomol was safe and well-tolerated at a dose of 400 mg administered orally three times daily throughout the 28-day trial period.
CytRx believes that results from this clinical trial, together with previously-announced clinical data from a rising multiple dose study reported in June 2007, support the use of arimoclomol in future clinical trials, including its planned ALS Phase IIb efficacy trial, at a dose four-fold higher than administered in its prior Phase IIa and open label extension clinical trials for ALS.
"This clinical trial builds on results of our previously-announced short-term rising multiple dose study by demonstrating that arimoclomol is equally as safe and well tolerated at 400 mg administered three times daily in a larger number of volunteers treated over a longer time duration," said CytRx's President and CEO Steven A. Kriegsman.
“We now have additional clinical support for our decision to administer arimoclomol at this higher dose in our upcoming ALS and stroke recovery clinical trials. We continue on track to initiate our Phase IIb efficacy trial in ALS, subject to U.S. Food and Drug Administration (FDA) clearance, before the end of this year.”